YaoGeJuCDE public lists · weekly counts
National Drug-Review Weekly
The available CDE acceptance records list 402 drug applications between 18 December 2025 and 24 December 2025 (data as of 13 November 2026 06:00). Of these, generic applications numbered 76, covering 52 drug names.
2025/12/18 – 2025/12/24
- New acceptances this week
- 402
- Drugs with new generic filings (by drug name, de-duplicated)
- 52
- Accepted this week, now under review
- 82
DefinitionAcceptance numbers accepted this week that still appear on CDE's under-review list at the data cutoff; counted by acceptance date from the daily full pull of that list, independent of snapshot history.
Names with a public page are linked.
New acceptances this week
By application type and drug type
402filings, 76 of them generic
By application type
| Application type | Filings |
|---|---|
| Supplement | 202 |
| New drug | 91 |
| Generic | 76 |
| Unspecified | 15 |
| Import | 11 |
| Import re-registration | 7 |
By drug type
| Drug type | Filings |
|---|---|
| Chemical drug | 191 |
| TCM | 123 |
| Therapeutic biologic | 79 |
| Biologic | 5 |
| Prophylactic biologic | 4 |
DefinitionAcceptance numbers whose acceptance date falls in this week; application type and drug type are the CDE list's own text, with empty values shown as “Unspecified”.
Most new generic filings, by drug
52 drugs with new generic filings; top 10 listed
| # | Drug | New generic filings | Filing companies | Under review, all years |
|---|---|---|---|---|
| 1 | Baricitinib Tablets | 3 | 2 | 32 |
| 2 | Lidocaine and Prilocaine Cream | 3 | 1 | 24 |
| 3 | Sildenafil Citrate Tablets | 3 | 1 | 12 |
| 4 | Oseltamivir Phosphate Capsules | 3 | 1 | 39 |
| 5 | 草酸艾司西酞普兰口服溶液 · No verified English name | 3 | 1 | 11 |
| 6 | 西诺氨酯片 · No verified English name | 3 | 1 | 24 |
| 7 | Colistimethate Sodium for Injection | 2 | 2 | 2 |
| 8 | Glucosamine Sulfate Capsules | 2 | 2 | 51 |
| 9 | Ilaprazole Enteric-coated Tablets | 2 | 2 | 26 |
| 10 | 利伐沙班口崩片 · No verified English name | 2 | 1 | 4 |
DefinitionThis week's acceptance numbers with application type “Generic”, grouped by identical drug name; filing companies are de-duplicated by first applicant; under review, all years = acceptance numbers for that name, from any year, still on the CDE under-review list. Top 10 by filings, then companies.
Most new acceptances, by company
217 companies with new acceptances; top 10 listed
| # | Company (first applicant) | Filings | Drugs | Generic |
|---|---|---|---|---|
| 1 | Jilin Sheng De Shang Pharma Co., Ltd. romanized | 46 | 39 | 0 |
| 2 | Ha Yao Group Shi Yi Tang Pharmaceutical Factory romanized | 14 | 14 | 0 |
| 3 | Amgen Inc. | 12 | 1 | 0 |
| 4 | Chengdu Bai Li Duo Te Bio Pharma Co., Ltd. romanized | 10 | 2 | 0 |
| 5 | Beijing Tong Ren Tang Technology Development Co., Ltd. Pharmaceutical Factory romanized | 5 | 5 | 0 |
| 6 | Merck Sharp & Dohme LLC | 5 | 3 | 0 |
| 7 | Hunan Qian Jin Xiang Jiang Pharma Co., Ltd. romanized | 5 | 3 | 5 |
| 8 | Name not romanized | 5 | 2 | 0 |
| 9 | Chengdu Di Ao Group Tian Fu Pharma Co., Ltd. romanized | 5 | 2 | 0 |
| 10 | Beijing Lian Er Tang Pharma Co., Ltd. romanized | 4 | 4 | 0 |
DefinitionThis week's acceptance numbers grouped by first applicant; drugs are de-duplicated by drug name; “Generic” counts filings with application type “Generic”. Top 10 by filings.
Under-review list changes
Compared across this platform's snapshots of the under-review list
Data collected since 2026/10/22. There is not enough snapshot history for this week yet; counts of filings entering and leaving review start with the next complete week.
DefinitionEntered review = acceptance numbers seen for the first time in this platform's under-review snapshots this week, excluding the baseline records of the first snapshot day (2026/10/22). Left review = acceptance numbers whose last snapshot sighting falls in this week and that this snapshot no longer lists; the outcome follows NMPA's approval-document delivery notices, and numbers without such a record are marked to be checked. Companies are counted by first applicant.
Class 3 and new-drug acceptances
121 this week
| Accepted | Drug | Applicants |
|---|---|---|
| 2025/12/24Import · Class 1 | 戈鲁利单抗注射液 · No verified English nameJXSS2500153 | Alexion Europe SAS; Patheon Italia S.P.A.; AstraZeneca Global R&D (China) Co. Ltd. |
| 2025/12/24Import · Class 1 | 戈鲁利单抗注射液 · No verified English nameJXSS2500152 | Alexion Europe SAS; Patheon Italia S.P.A.; AstraZeneca Global R&D (China) Co. Ltd. |
| 2025/12/24Import · Class 1 | DAK539片 · No verified English nameJXHL2500391 | Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd. |
| 2025/12/24Import · Class 1 | DAK539片 · No verified English nameJXHL2500390 | Novartis Pharma AG; China Novartis Institutes for BioMedical Research Co. Ltd. |
| 2025/12/24Generic · Class 3 | Betaine anhydrous for oral solutionCYHS2504363 | Beijing Si Li An Pharma Co., Ltd. romanized |
| 2025/12/24Generic · Class 3 | 奥美拉唑镁/阿莫西林/利福布汀肠溶胶囊 · No verified English nameCYHL2500229 | Shandong Qidu Pharmaceutical Co., Ltd. |
| 2025/12/24New drug · Class 1.1 | KLN01颗粒 · No verified English nameCXZL2500134 | Nanjing Ke Ling Pharmaceuticals Technology Co., Ltd. romanized |
| 2025/12/24New drug · Class 2.3 | 虚汗停颗粒 · No verified English nameCXZL2500133 | Guangzhou Bai Yun Shan Qi Xing Pharma Co., Ltd. romanized |
| 2025/12/24New drug · Class 1 | 莱康奇塔单抗注射液 · No verified English nameCXSS2500144 | Zhuhai Shi Li Zhu Dan Kang Bio Technology Co., Ltd. romanized |
| 2025/12/24New drug · Class 1 | GO321重组溶瘤痘苗病毒注射液 · No verified English nameCXSL2501123 | Shanghai Jin Si Bio Technology Co., Ltd. romanized |
| 2025/12/24New drug · Class 1 | TQB6457注射液 · No verified English nameCXSL2501122 | Shanghai Zheng Da Tian Qing Pharmaceuticals Technology Kai Fa Co., Ltd. romanized |
| 2025/12/24New drug · Class 1 | 注射用VRT106 · No verified English nameCXSL2501121 | Guangzhou Wei Rong Te Pharmaceuticals Technology Co., Ltd. romanized |
| 2025/12/24New drug · Class 2.2; 2.4 | 注射用KJ101 · No verified English nameCXSL2501119 | Shanghai Bao Ji Pharma Co., Ltd. romanized |
| 2025/12/24New drug · Class 1 | SHR-3836注射液 · No verified English nameCXSL2501118 | Shanghai Heng Rui Pharmaceuticals Co., Ltd. romanized |
| 2025/12/24New drug · Class 1 | SHR-3836注射液 · No verified English nameCXSL2501117 | Shanghai Heng Rui Pharmaceuticals Co., Ltd. romanized |
| 2025/12/24New drug · Class 1 | 酒石酸凡瑞格拉替尼片 · No verified English nameCXHS2500162 | He Ji Huang Pu Pharmaceuticals (Shanghai) Co., Ltd. romanized |
| 2025/12/24New drug · Class 2.3 | BCM894胶囊 · No verified English nameCXHS2500161 | Hainan Jin Rui Bao Pharmaceuticals Technology Co., Ltd. romanized; Bo Zhi Yan Xin Tai Zhou Drug Technology Co., Ltd. romanized |
| 2025/12/24New drug · Class 1 | RBD5044注射液 · No verified English nameCXHL2501448 | Rui Bo Tai Ke (Shandong) Biopharmaceuticals Technology Co., Ltd. romanized |
| 2025/12/24New drug · Class 1 | 108MCN鼻喷雾剂 · No verified English nameCXHL2501447 | Beijing Shuo Bai Pharmaceuticals Technology Co., Ltd. romanized; Anhui Shuo Bai Pharmaceutical Co., Ltd. romanized |
| 2025/12/24New drug · Class 1 | CMS-D008注射液 · No verified English nameCXHL2501446 | Shenzhen Shi Kang Zhe Bio Technology Co., Ltd. romanized |
| 2025/12/23Import · Class 1 | Frexalimab注射液 · No verified English nameJXSL2500245 | Sanofi-Aventis Recherche & Développement; Sanofi (China) Investment Co. Ltd. |
| 2025/12/23Generic · Class 3 | Haloperidol Oral SolutionCYHS2504360 | Hainan Si Da Pharmaceutical Co., Ltd. romanized |
| 2025/12/23Generic · Class 3 | Paracetamol And Ibuprofen Oral SuspensionCYHS2504357 | Huayi Pharmaceuticals (Anhui) Co., Ltd. |
| 2025/12/23Generic · Class 3 | 贝美前列素涂剂 · No verified English nameCYHL2500228 | NANJING ZENKOM PHARMACEUTICAL CO.,LTD. |
| 2025/12/23Generic · Class 3 | Colistimethate Sodium for InjectionCYHL2500227 | Hebei Sheng Xue Da Cheng Pharmaceutical Co., Ltd. romanized |
| 2025/12/23Generic · Class 3 | 氟[18F]妥西吡注射液 · No verified English nameCYHL2500226 | Hangzhou Yi Li Pharmaceuticals Co., Ltd. romanized |
| 2025/12/23New drug · Class 3.3 | QL2109注射液 · No verified English nameCXSL2501120 | Qilu Pharmaceutical Co., Ltd. |
| 2025/12/23New drug · Class 1 | JWK001注射液 · No verified English nameCXSL2501116 | Chengdu Jin Wei Ke Bio Technology Co., Ltd. romanized |
| 2025/12/23New drug · Class 1 | 注射用BL-B01D1 · No verified English nameCXSL2501115 | Chengdu Bai Li Duo Te Bio Pharma Co., Ltd. romanized; Sichuan Bai Li Pharma Co., Ltd. romanized |
| 2025/12/23New drug · Class 1 | 注射用BL-B01D1 · No verified English nameCXSL2501114 | Chengdu Bai Li Duo Te Bio Pharma Co., Ltd. romanized; Sichuan Bai Li Pharma Co., Ltd. romanized |
91 more not listed (at most 30 rows).
DefinitionThis week's acceptance numbers with application type “New drug”, or registration applications whose class starts with 1, 2 or 3 (supplements and re-registrations excluded); newest first, at most 30 rows.
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